Diabetic Peripheral Neuropathy (DPN)NCT07551726
Effect of Low-Frequency Electroacupuncture on Diabetic Peripheral Neuropathy
A study testing EA in people with Diabetic Peripheral Neuropathy (DPN) and Electroacupuncture, run by The First Affiliated Hospital of Zhejiang Chinese Medical University.
Trial summary
Diabetic peripheral neuropathy (DPN) is a common and disabling complication of diabetes. Many patients experience pain, numbness, and impaired quality of life, while currently available treatments may have limited benefit or cause adverse effects. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy (DPN), Electroacupuncture
- What is being tested?
- EA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 26 Apr 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Aged 18-70 years, with no restriction on disease duration or sex. 2.Met the diagnostic criteria for DPN, evidenced by: decreased NCV on lower-limb electroneurography, and/or persistent pain and/or sensory abnormalities in the limbs (at least in both lower limbs), with diminished ankle reflex (unilateral or bilateral) and reduced vibration sense, and a Toronto Clinical Scoring System (TCSS) score ≥ 6.
- 3.Able to communicate effectively. 4.No severe systemic medical conditions (e.g., cardiac, cerebral, hepatic, or renal disorders), severe psychiatric illnesses, or cognitive impairment.
- 5.Mentally competent, voluntarily agree to participate in the study, and provide written informed consent.
Who cannot join
- 1.Peripheral neuropathy due to other etiologies (e.g., hypothyroidism, alcohol, medications, hereditary causes), presence of limb ulcers or gangrene, or a history of skin ulceration or poorly healing lesions.
- 2.Severe comorbid conditions, including renal, cardiovascular, cerebrovascular, pulmonary, or hepatic diseases, infectious diseases, malignancies, or severe psychiatric disorders.
- 3.History of knee/hip replacement surgery or lower limb fracture within the past 3 months, or any other condition that could interfere with the assessment of neuropathy.
- 4.Received acupuncture or moxibustion treatment specifically for DPN within the past 3 months.
- 5.Concurrent participation in another interventional clinical trial. 6.Women who are planning pregnancy, are pregnant, or are lactating. 7.Unwillingness to be randomized to either the waitlist (WL) or EA group. 8.Chronic abuse of opioids, analgesics, illicit drugs, or alcohol.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Low-Frequency Electroacupuncture on Diabetic Peripheral Neuropathy: Study Protocol for a Randomized Controlled Trial
Diabetic peripheral neuropathy (DPN) is a common and disabling complication of diabetes. Many patients experience pain, numbness, and impaired quality of life, while currently available treatments may have limited benefit or cause adverse effects. Electroacupuncture (EA) may provide a safe, non-pharmacological treatment option, but further clinical evidence is needed.
The purpose of this study is to evaluate the efficacy and potential mechanisms of low-frequency (2 Hz) electroacupuncture in patients with DPN. In this prospective, randomized, sham-controlled trial, participants will be assigned to either a verum 2 Hz EA group or a sham EA group. The study will assess nerve conduction velocity, pain intensity, serum neurotrophic factors and inflammatory cytokines, and quality of life.
This study is intended to provide clinical evidence on the use of low-frequency EA for DPN and to examine whether its effects are related to neurotrophic and inflammatory pathways.
- Being tested
- EA, Sham EA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EAOther
Disposable sterile acupuncture needles (Hwato brand) in sizes of 0.18 mm × 25 mm and 0.25 mm × 40 mm were used. Following skin disinfection with 75% alcohol swabs, needles were inserted at selected acupoints to elicit a deqi sensation, characterized by local soreness, numbness, or distension reported by the participant.
Sham EAOther
Superficial insertion to a depth of approximately 1-2 mm was performed at these sites using Hwato brand disposable sterile acupuncture needles (0.18 mm × 25 mm). A Hwato SDZ-IIB electronic acupuncture stimulator with deliberately impaired connecting leads was attached to the needles at the sham sites. After the device was turned on and the frequency and intensity parameters were visibly set on the display screen, participants underwent a 30-minute needle retention period. Although the stimulator screen remained active, no actual electrical current was delivered to the needles throughout the session.
| Study group | Role | What they receive |
|---|---|---|
| EA | Experimental | The primary acupoints, included GB34, ST36, ST39 GB39, SP9, SP6,ST41, LR3, and GB41. Supplementary acupoints were added based on clinical presentation: BL60, ST44, and EX-LE10 for significant lower limb pain; and LI11，LI10) SJ5,LI4, and EX-UE9 for concomitant upper limb pain. Disposable sterile acupuncture needles (Hwato brand) in sizes of 0.18 mm × 25 mm and 0.25 mm × 40 mm were used. Following skin disinfection with 75% alcohol swabs, needles were inserted at selected acupoints to elicit a deqi sensation, characterized by local soreness, numbness, or distension reported by the participant. Receives: Other: EA |
| Sham EA | Sham comparator | In the sham EA group, two non-acupoint locations on each lower limb were selected. Superficial insertion to a depth of approximately 1-2 mm was performed at these sites using Hwato brand disposable sterile acupuncture needles (0.18 mm × 25 mm). A Hwato SDZ-IIB electronic acupuncture stimulator with deliberately impaired connecting leads was attached to the needles at the sham sites. After the device was turned on and the frequency and intensity parameters were visibly set on the display screen, participants underwent a 30-minute needle retention period. Although the stimulator screen remained active, no actual electrical current was delivered to the needles throughout the session. Receives: Other: Sham EA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower limb nerve conduction velocity
Lower limb nerve conduction velocity (NCV) will be measured at baseline and at the end of the 6-week intervention. Assessments will include motor NCV and sensory NCV of the bilateral common peroneal nerves and tibial nerves.
Measured: Baseline (week 0) and week 6 (±3 days)
Overall clinical response rate
Overall clinical response rate will be assessed at the end of the 6-week treatment period. Treatment efficacy will be categorized into three levels: marked effective, effective, and ineffective. Marked effective will be defined as significant subjective symptom relief accompanied by an increase in nerve conduction velocity (NCV) of ≥5 m/s on electromyography, or recovery to near-normal levels. Effective will be defined as subjective clinical improvement with an NCV increase of <5 m/s. Ineffective will be defined as no significant improvement in clinical symptoms, tendon reflexes, sensory perception, or NCV. The overall clinical response rate will be calculated as (number of marked effective cases + number of effective cases) / total number of participants × 100%.
Measured: At the end of week 6 (±3 days).
Secondary outcomes (10)
Visual Analog Scale score
The Visual Analog Scale (VAS) will be used to assess pain, numbness, and burning sensations. Scores range from 0 to 10, with higher scores indicating more severe symptoms.
Measured: At baseline (week 0), week 3 (±3 days), week 6 (±3 days), and week 10 (±3 days)
Toronto Clinical Scoring System score
The Toronto Clinical Scoring System (TCSS) will be used to assess the severity of diabetic peripheral neuropathy. The TCSS is a 19-point composite scale consisting of symptom, reflex, and sensory test components. Higher scores indicate greater severity of neuropathy.
Measured: At baseline (week 0), week 3 (±3 days), week 6 (±3 days), and week 10 (±3 days)
Diabetes Quality of Life scale score
The Diabetes Quality of Life (DQoL) scale will be used to assess quality of life. In the version used in this study, the total score ranges from 27 to 135, with lower scores indicating better quality of life.
Measured: At baseline (week 0), week 3 (±3 days), week 6 (±3 days), and week 10 (±3 days)
Serum nerve growth factor concentration
Fasting peripheral venous blood samples will be collected in the morning at each assessment time point. Serum nerve growth factor (NGF) concentration will be measured using enzyme-linked immunosorbent assay (ELISA).
Measured: At baseline (week 0), week 3 (±3 days), week 6 (±3 days)
Serum brain-derived neurotrophic factor concentration
Fasting peripheral venous blood samples will be collected in the morning at each assessment time point. Serum brain-derived neurotrophic factor (BDNF) concentration will be measured using enzyme-linked immunosorbent assay (ELISA).
Measured: At baseline (week 0), week 3 (±3 days), week 6 (±3 days)
Serum tumor necrosis factor-alpha concentration
Fasting peripheral venous blood samples will be collected in the morning at each assessment time point. Serum tumor necrosis factor-alpha (TNF-alpha) concentration will be measured using enzyme-linked immunosorbent assay (ELISA).
Measured: At baseline (week 0), week 3 (±3 days), week 6 (±3 days)
Serum interleukin-6 concentration
Fasting peripheral venous blood samples will be collected in the morning at each assessment time point. Serum interleukin-6 (IL-6) concentration will be measured using enzyme-linked immunosorbent assay (ELISA).
Measured: At baseline (week 0), week 3 (±3 days), week 6 (±3 days)
Hemoglobin A1c
Hemoglobin A1c (HbA1c) will be measured to assess glycemic control.
Measured: At baseline (week 0), week 6 (±3 days),
Fasting plasma glucose
Fasting plasma glucose (FPG) will be measured to assess glycemic control.
Measured: At baseline (week 0), week 3 (±3 days), week 6 (±3 days), and week 10 (±3 days)
2-hour postprandial glucose
Two-hour postprandial glucose (2hPG) will be measured to assess glycemic control.
Measured: At baseline (week 0), week 3 (±3 days), week 6 (±3 days), and week 10 (±3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start26 Apr 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral Neuropathy (DPN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551726
- Sponsor's protocol ID
- 2026-KL-189-01-DPN
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen N, Li R, Luo N. Low-Frequency Electroacupuncture versus Sham Electroacupuncture for Diabetic Peripheral Neuropathy: Study Protocol for a Randomized Controlled Trial. Diabetes Metab Syndr Obes. 2026 Sep 30;19:620786. doi: 10.2147/DMSO.S620786. eCollection 2026.
PubMed 42830957
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-Frequency Electroacupuncture on Diabetic Peripheral Neuropathy: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07551726
- Acronym / sponsor ID
- 2026-KL-189-01-DPN
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Collaborators
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Study start
- 26 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetic peripheral neuropathy (DPN) is a common and disabling complication of diabetes. Many patients experience pain, numbness, and impaired quality of life, while currently available treatments may have limited benefit or cause adverse effects. Electroacupuncture (EA) may provide a safe, non-pharmacological treatment option, but further clinical evidence is needed.
The purpose of this study is to evaluate the efficacy and potential mechanisms of low-frequency (2 Hz) electroacupuncture in patients with DPN. In this prospective, randomized, sham-controlled trial, participants will be assigned to either a verum 2 Hz EA group or a sham EA group. The study will assess nerve conduction velocity, pain intensity, serum neurotrophic factors and inflammatory cytokines, and quality of life.
This study is intended to provide clinical evidence on the use of low-frequency EA for DPN and to examine whether its effects are related to neurotrophic and inflammatory pathways.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EA | Experimental | Other: EAThe primary acupoints, included GB34, ST36, ST39 GB39, SP9, SP6,ST41, LR3, and GB41. Supplementary acupoints were added based on clinical presentation: BL60, ST44, and EX-LE10 for significant lower limb pain; and LI11，LI10) SJ5,LI4, and EX-UE9 for concomitant upper limb pain. Disposable sterile acupuncture needles (Hwato brand) in sizes of 0.18 mm × 25 mm and 0.25 mm × 40 mm were used. Following skin disinfection with 75% alcohol swabs, needles were inserted at selected acupoints to elicit a deqi sensation, characterized by local soreness, numbness, or distension reported by the participant. |
| Sham EA | Sham comparator | Other: Sham EAIn the sham EA group, two non-acupoint locations on each lower limb were selected. Superficial insertion to a depth of approximately 1-2 mm was performed at these sites using Hwato brand disposable sterile acupuncture needles (0.18 mm × 25 mm). A Hwato SDZ-IIB electronic acupuncture stimulator with deliberately impaired connecting leads was attached to the needles at the sham sites. After the device was turned on and the frequency and intensity parameters were visibly set on the display screen, participants underwent a 30-minute needle retention period. Although the stimulator screen remained active, no actual electrical current was delivered to the needles throughout the session. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1.Aged 18-70 years, with no restriction on disease duration or sex. 2.Met the diagnostic criteria for DPN, evidenced by: decreased NCV on lower-limb electroneurography, and/or persistent pain and/or sensory abnormalities in the limbs (at least in both lower limbs), with diminished ankle reflex (unilateral or bilateral) and reduced vibration sense, and a Toronto Clinical Scoring System (TCSS) score ≥ 6.
- 3.Able to communicate effectively. 4.No severe systemic medical conditions (e.g., cardiac, cerebral, hepatic, or renal disorders), severe psychiatric illnesses, or cognitive impairment.
- 5.Mentally competent, voluntarily agree to participate in the study, and provide written informed consent.
Key exclusion criteria (5 listed)
- 1.Peripheral neuropathy due to other etiologies (e.g., hypothyroidism, alcohol, medications, hereditary causes), presence of limb ulcers or gangrene, or a history of skin ulceration or poorly healing lesions.
- 2.Severe comorbid conditions, including renal, cardiovascular, cerebrovascular, pulmonary, or hepatic diseases, infectious diseases, malignancies, or severe psychiatric disorders.
- 3.History of knee/hip replacement surgery or lower limb fracture within the past 3 months, or any other condition that could interfere with the assessment of neuropathy.
- 4.Received acupuncture or moxibustion treatment specifically for DPN within the past 3 months.
- 5.Concurrent participation in another interventional clinical trial. 6.Women who are planning pregnancy, are pregnant, or are lactating. 7.Unwillingness to be randomized to either the waitlist (WL) or EA group. 8.Chronic abuse of opioids, analgesics, illicit drugs, or alcohol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EADisposable sterile acupuncture needles (Hwato brand) in sizes of 0.18 mm × 25 mm and 0.25 mm × 40 mm were used. Following skin disinfection with 75% alcohol swabs, needles were inserted at selected acupoints to elicit a deqi sensation, characterized by local soreness, numbness, or distension reported by the participant. | Other | EA |
| Sham EASuperficial insertion to a depth of approximately 1-2 mm was performed at these sites using Hwato brand disposable sterile acupuncture needles (0.18 mm × 25 mm). A Hwato SDZ-IIB electronic acupuncture stimulator with deliberately impaired connecting leads was attached to the needles at the sham sites. After the device was turned on and the frequency and intensity parameters were visibly set on the display screen, participants underwent a 30-minute needle retention period. Although the stimulator screen remained active, no actual electrical current was delivered to the needles throughout the session. | Other | Sham EA |
Primary outcome
Lower limb nerve conduction velocity
Time frame: Baseline (week 0) and week 6 (±3 days)
Lower limb nerve conduction velocity (NCV) will be measured at baseline and at the end of the 6-week intervention. Assessments will include motor NCV and sensory NCV of the bilateral common peroneal nerves and tibial nerves.
Overall clinical response rate
Time frame: At the end of week 6 (±3 days).
Overall clinical response rate will be assessed at the end of the 6-week treatment period. Treatment efficacy will be categorized into three levels: marked effective, effective, and ineffective. Marked effective will be defined as significant subjective symptom relief accompanied by an increase in nerve conduction velocity (NCV) of ≥5 m/s on electromyography, or recovery to near-normal levels. Effective will be defined as subjective clinical improvement with an NCV increase of <5 m/s. Ineffective will be defined as no significant improvement in clinical symptoms, tendon reflexes, sensory perception, or NCV. The overall clinical response rate will be calculated as (number of marked effective cases + number of effective cases) / total number of participants × 100%.
10 secondary outcomes
Visual Analog Scale score
Time frame: At baseline (week 0), week 3 (±3 days), week 6 (±3 days), and week 10 (±3 days)
Toronto Clinical Scoring System score
Time frame: At baseline (week 0), week 3 (±3 days), week 6 (±3 days), and week 10 (±3 days)
Diabetes Quality of Life scale score
Time frame: At baseline (week 0), week 3 (±3 days), week 6 (±3 days), and week 10 (±3 days)
Serum nerve growth factor concentration
Time frame: At baseline (week 0), week 3 (±3 days), week 6 (±3 days)
Serum brain-derived neurotrophic factor concentration
Time frame: At baseline (week 0), week 3 (±3 days), week 6 (±3 days)
Serum tumor necrosis factor-alpha concentration
Time frame: At baseline (week 0), week 3 (±3 days), week 6 (±3 days)
Serum interleukin-6 concentration
Time frame: At baseline (week 0), week 3 (±3 days), week 6 (±3 days)
Hemoglobin A1c
Time frame: At baseline (week 0), week 6 (±3 days),
Fasting plasma glucose
Time frame: At baseline (week 0), week 3 (±3 days), week 6 (±3 days), and week 10 (±3 days)
2-hour postprandial glucose
Time frame: At baseline (week 0), week 3 (±3 days), week 6 (±3 days), and week 10 (±3 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Derived from this study: PubMed 42830957Chen N, Li R, Luo N. Low-Frequency Electroacupuncture versus Sham Electroacupuncture for Diabetic Peripheral Neuropathy: Study Protocol for a Randomized Controlled Trial. Diabetes Metab Syndr Obes. 2026 Sep 30;19:620786. doi: 10.2147/DMSO.S620786. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing EA in people with Diabetic Peripheral Neuropathy (DPN) and Electroacupuncture, run by The First Affiliated Hospital of Zhejiang Chinese Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ning Luo (+8615083521014, 921941696@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower limb nerve conduction velocity (time frame: Baseline (week 0) and week 6 (±3 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07551726, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.